Ross Segan was chosen to lead the office, which handles premarket authorizations and recalls, in the agency’s Center for Devices and Radiological Health.

EBR Systems (ASX:EBR) announces the US FDA has accepted its final premarket approval application for the WiSE CRT System.

Recommended Reading FDA defends Shuren’s tenure after report raises ethics concerns The Food and Drug Administration named Ross Segan as director of the medical device center’s Office of ...

Pfizer withdraws OXBRYTA after post marketing studies showed that the risks of side effects were greater than the benefits.

Eli Lilly's Ebglyss gains FDA approval for atopic dermatitis treatment, poised to rival Dupixent with strong performance in ...

The U.S. agriculture industry is bracing for production delays and other consequences if workers at ports on the Eastern Seaboard and Gulf Coast strike.

Answers Pet Food and Darwin’s Natural Pet Products, were found to have produced pet food that was contaminated with the ...

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here. In a new ...

An on-demand video of “Everyone’s Targeting Seafood – CBP Forced Labor, Proposition 65, PFAS, and FDA” is available free for ...

ASX could hit record high despite mixed bag on Wall Street. US stocks expected to outperform bonds as Fed cuts rates.